Stryker Recalls Naera Hospital Bassinet Mattresses Due to Air Expansion Risk
Stryker is recalling Naera Hospital Bassinet mattresses because air expansion at high altitudes may create gaps, posing a risk of patients rolling over.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (patient rolling over) where the highest possible severity is death, but no injuries or illnesses have been reported.
Plain-English summary
Stryker Medical Division of Stryker Corporation is recalling 5,915 units of the Naera Hospital Bassinet, Model No. 4402. The recall involves the mattresses used in these bassinets, which were distributed nationwide and to 15 foreign countries including Argentina, Australia, Canada, and the United Kingdom.
The recall was initiated after it was identified that the volume of air inside the mattress may expand in regions of high altitude. This expansion can result in an unintended gap between the plateau of the inflated patient surface and the tub. A Health Hazard Evaluation identified the potential risk of patients moving out of position and rolling over on the mattress. While the highest possible severity of harm associated with this condition is death, there have been no reports of injury or harm to date.
Although the condition has only presented in regions of high altitude, Stryker has chosen to replace all Naera mattresses in the field. Hospitals and facilities should check their inventory for the affected serial numbers listed in the official recall notice and contact Stryker for replacement instructions.
The recalled product
- Product
- Naera Hospital Bassinet, Model No. 4402
- Manufacturer
- Stryker Medical Division of Stryker Corporation
- Affected units
- 5,915
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Stryker Medical Division of Stryker Corporation
See all →- ModerateStryker Cub pediatric cribs sold in USA missing two warning labels
FDA (Devices) · 2026-03-25
- ModerateBariatric hospital beds recalled because they are not tested with certain mattresses
FDA (Devices) · 2025-12-17
- ModerateHospital mattresses recalled because they are not tested with certain beds
FDA (Devices) · 2025-12-17
- HighProCurity patient beds recalled for electrical safety testing defects
FDA (Devices) · 2023-12-13
- HighProCuity Hospital Patient Beds Recalled for Missing Electrical Safety Testing
FDA (Devices) · 2023-12-13
Same hazard · fall injury
See all →- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Assembly Disconnect Risk
FDA (Devices) · 2026-10-14
- High
- HighForest River Recalls 2026-2027 Dynamax Isata RVs for Bunk Mat Alignment
NHTSA · 2026-09-23
- HighForest River Recalls 2026-2027 Dynamax Isata RVs Due to Ladder Defect
NHTSA · 2026-09-23
- HighBritax Recalls Infant Car Seats Due to Handle Detachment Risk
NHTSA · 2026-08-20
Similar recalls
- ModerateStryker MA204 Bed Recall Due to Loadcell Failure in Scale Function
FDA (Devices) · 2012-07-04
- HighStryker Spirit Plus Bed Recall for Potential Entrapment Risk
FDA (Devices) · 2018-11-21
- SevereStryker Mistral-Air Premium Blankets Recalled for Electrical Conductivity Risk
FDA (Devices) · 2018-02-07
- HighPenner Patient Stretcher/Transfer Lift System Recalled for Tipping Hazard
FDA (Devices) · 2015-04-01
- ModerateStryker Recalls Go Bed II+ Units Due to Scale and Bed Exit Failures
FDA (Devices) · 2012-07-04
- ModerateStryker Recalls Go Bed II+ Model FL 28 Ex Due to Scale Failures
FDA (Devices) · 2012-07-04